MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Perforation (2001); Iatrogenic Source (2498)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier not available on attached journal article. Patient age was estimated based on the journal article which mean age at surgery was 65. 1 year old. Therefore, 65 year old was used. Patient sex was selected based on the journal article which 54 male and 26 female. Therefore, male was used. Patient weight not available on attached journal article. Event date is approximated based on the published date of the article which is april 11, 2016. Citation: nobuyuki shimokawa, junya abe, hidetoshi satoh et al. Image-guided spine stabilization for traumatic or osteoporotic spine injury: radiological accuracy and neurological outcome. (2016). Neurol med chir (tokyo) 56, 493¿500; doi: 10. 2176/nmc. Oa. 2015-0334. The exact system information could not be determined as it was not provided. However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed. Device udi not provided as this product is no longer manufactured multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's intraoperative imaging and navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Not returned by customer.

Event Description

Medtronic representative reviewed the attached article on november 9, 2017, and forwarded it for evaluation for potential complaint reporting with intraoperative navigation system and imaging system. The igs spine fixation with or without minimally invasive surgery (mis) techniques such as percutaneous screw placement, balloon kyphoplasty (bkp), or vertebroplasty (vp) were accomplished in 80 patients with traumatic or osteoprotic spine injury between 2007 and 2015. The injured vertebral levels included the following: cervical spine, 41; thoracic spine, 22; and lumbar spine, 17. Neurological condition before and after surgery was assessed using the american spinal injury association impairment scale (ais). Grade 1, cortical perforation is present and the screw protrudes up to 2 mm; grade 2, cortical perforation is > 2 mm, but < 4 mm; and grade 3, cortical perforation > 4 mm. A total of 419 pedicle, lateral mass, or laminar screws were placed, and 399 screws (95. 2%) were found to be placed correctly based on postoperative computed tomography scan. Although 20 screws (4. 8%; 3. 1% (13 of 452 screws) in grade 1, 1. 7% (7 of 419 screws) in grade 2) were found to be unexpectedly placed incorrectly, no neural or vascular complications closely associated with screw placement were encountered. Neurological outcomes appeared to be acceptable or successful based on ais. The igs is a promising technique that can improve the accuracy of screw placement and reduce potential injury to critical neurovascular structures. The integration of mis and igs has proved feasible and safe in the treatment of traumatic or osteoporotic spine injury, although a thorough knowledge of surgical anatomy, spine biomechanics, and basic technique remain the most essential aspects for a successful surgery. In conclusion, the igs is a promising technique that can improve the accuracy of screw placement and reduce potential injury to critical neurovascular structures. The integration of mis and igs proved to be feasible and safe in the treatment of traumatic or osteoporotic spine injury, although a thorough knowledge of surgical anatomy, spine biomechanics, and basic technique remain the most essential aspects for successful surgery. An igs for traumatic or osteoporotic spine injury may represent the most current modification of spine surgery, and this has been an important advancement.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: koko tyler ; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7096957
• MDR Text Key: 94148303
• Report Number: 1723170-2017-05009
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/07/2017 Patient Sequence Number: 1